FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: PYRLess Group, Amarillo, TX (2/25): FDA has reviewed the firm’s Web sites (https://drfitt.com and https://drfittinfo.com) and
FDA Policy/General
HHS has published its semiannual regulatory agenda for all agencies within the department. The listing for FDA covers six items in the final rule stage and four completed actions.
FDA Policy/General
Former CDER associate director Jonathan Sackner-Bernstein says there five traits the Biden administration should be looking for in any candidate to become FDA commissioner: * focusing resources on clear, transparent, and consistent communication coupled with accepting responsibility for action and inaction, with the understanding that emerging scientific data can change
FDA Policy/General
7 No-Longer-Marketed ANDAs Withdrawn 03/25/2021 Federal Register notice: FDA is withdrawing approval of seven ANDAs from multiple applicants after they notified the agency that the drug products are no longer marketed and requested that they be withdrawn. To view the notice, click here. Info Collection on
FDA Policy/General
Federal Register notice: FDA is announcing the user fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for fiscal year 2021. The fee for a OTC Monograph Order Request Tier 1 is $500,000 and Tier 2 is $100,000. Tier 1 requests include new OTC
FDA Policy/General
Federal Register notice: FDA has announced a 5/6 Arthritis Advisory Committee meeting. Panel members are scheduled to discuss a ChemoCentryx NDA for avacopan oral capsules, indicated for treating anti-neutrophil cytoplasmic antibody-associated vasculitis. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is issuing an order to debar Ursula Wing for a period of five years from importing or offering for import any drug into the U.S. FDA bases the order on a finding that she was convicted of one felony count under federal law related to
FDA Policy/General
Federal Register notice: FDA is publishing a list of seven information collections that have been approved by OMB. They are: * Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies * Orphan Drugs * Electronic Records: Electronic Signatures * Extra Label Drug Use in Animals * Reporting and Recordkeeping Requirements for Human Food and Cosmetics
FDA Policy/General
Federal Register notice: FDA has issued an order to debar for 10 years Thomas J. Whalen from importing or offering for import any drug into the U.S. FDA based this action on his conviction related to importing and distributing misbranded and non-FDA-approved injectable drugs. To view the
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for CVRx’s Barostim Neo, indicated for improving symptoms of heart failure, quality of life, six-minute hall walk and functional status for patients who remain symptomatic despite treatment with guideline-directed medical therapy. The regulatory
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that discuss the design of bioequivalence studies to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels to notify FDA in writing. FDA is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory
FDA Policy/General
Federal Register notice: FDA has determined that 20 drug products were not withdrawn from sale for safety or effectiveness reasons. The determination means that the agency will not begin procedures to withdraw ANDAs that refer the drug products, and it will continue to approve ANDAs that refer to the products
FDA Policy/General
Federal Register notice: FDA has revised its list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need in drug compounding. The notice identifies one bulk drug substance that FDA has considered and proposes to include on its list — quinacrine hydrochloride. Additionally, FDA has identified four
FDA Policy/General
Federal Register notice: FDA is announcing a 6/23 public workshop entitled “FY 2021 Generic Drug Science and Research Initiatives Workshop.” The workshop is intended to provide an overview of science and research initiatives for generic drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is publishing a list of PMAs that have been approved from 10/1/2018 through 12/31/2020. The list is intended to inform the public of the availability of the PMA safety and effectiveness summaries. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for a 10/28 notice entitled “The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; Request for Comments.” Electronic or written comments can now be submitted by 6/22. To view the notice, click
FDA Policy/General
FDA principal deputy commissioner and acting chief information officer Amy Abernethy will be leaving the agency in the next few weeks. “Throughout multiple commissioner transitions and a historic pandemic, Amy’s focus on the FDA’s core technology operations has resulted in a remarkable modernization of the agency’s technology
FDA Policy/General
SUNSET Rule Effective Date Postponed 03/19/2021 Federal Register notice: HHS is postponing, pending judicial review, the effective date of a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET final rule) that was published 1/19. The SUNSET final rule was scheduled to take effect 3/
FDA Policy/General
Federal Register notice: HHS is postponing, pending judicial review, the effective date of a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET final rule) that was published 1/19. The SUNSET final rule was scheduled to take effect 3/22. However, on 3/9 a lawsuit was
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during July, August, and September 2020. FDA is also making available summaries of the basis of approval and environmental review documents, where applicable. To
FDA Policy/General
California attorney general Xavier Becerra was confirmed by the U.S. Senate 3/18 as HHS secretary, a move that could expedite the nomination of an FDA commissioner. The delay in nominating a commissioner has been noteworthy among FDA observers (see earlier story), with many acknowledging that two earlier prospects